MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-06 for JACOBSON MOSQUITO FORCEP DEL CVD JAW 5IN CH8610 manufactured by Carefusion, Inc.
[128262366]
(b)(4). On 16oct2018 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event. Writer provided contact information. Device not yet evaluated; if the device is evaluated a follow up will be sent.
Patient Sequence No: 1, Text Type: N, H10
[128262367]
It was reported via email: during procedure, the tip of one side jaw was broken, which occurred on two devices out of four. The user purchased four devices in may and insisted that how they maintained the devices was the same but only two had been broken. No patient harm. Procedure being performed: unknown. On 18oct2018, additional information: did any part the instrument fall into the patient? S body, and if so how was it retrieved? Instrument (1) with the broken tip: it was broken during surgery so the tip should have fallen into the patient? S body and retrieved but how it was retrieved was unknown. Instrument (2) without the broken tip: the hospital noticed that a broken tip was missing during cleaning process and still has not yet returned. Since the hospital didn? T mention after experiencing the instrument (1), we think it was broken after the surgery. Was there a medical procedure performed to verify if the instrument was in the patient? S body, such as an x-ray? Unknown. What was the patient? S outcome? Unknown. Was the procedure completed as planned? Yes. The surgeon used a replacement and completed the surgery as planned. On 26oct2018, additional information: yes, the instrument 2 was also used on a patient but not known when the tip was broken. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2018-00020 |
| MDR Report Key | 8042344 |
| Date Received | 2018-11-06 |
| Date of Report | 2018-12-06 |
| Date of Event | 2018-09-27 |
| Date Mfgr Received | 2018-10-19 |
| Device Manufacturer Date | 2018-03-01 |
| Date Added to Maude | 2018-11-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | JACOBSON MOSQUITO FORCEP DEL CVD JAW 5IN |
| Generic Name | SCISSORS, GENERAL, SURGICAL |
| Product Code | DWS |
| Date Received | 2018-11-06 |
| Returned To Mfg | 2018-10-19 |
| Catalog Number | CH8610 |
| Lot Number | C18XQS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Brand Name | JACOBSON MOSQUITO FORCEP DEL CVD JAW 5IN |
| Generic Name | SCISSORS, GENERAL, SURGICAL |
| Product Code | DWS |
| Date Received | 2018-11-06 |
| Returned To Mfg | 2018-10-19 |
| Catalog Number | CH8610 |
| Lot Number | C18XQS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-06 |